Effectiveness of Sugammadex Versus Neostigmine on the Reversal of Rocuronium-induced Neuromuscular Blockade in Patients With Myasthenia Gravis After Thoracoscopic Thymectomy: A Multicenter Randomized Controlled Trial

TRRCKY202 l-009-GZ (2023)-003

The purpose of this study was to demonstrate in patients with myasthenia gravis (MG) undergoing thoracoscopic thymectomy faster recovery from a moderate neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 mg/kg sugammadex compared to 50 ug/kg neostigmine. Methods: A total of 64 patients with MG undergoing thoracoscopic thymectomy will be randomly divided into two groups: Sugammadex group (S group) and Neostigmine group (N group). The same anesthesia methods will be applied in both groups. Patients of S group will receive a dose of 2.0 mg/kg sugammadex after the last dose of rocuronium, at reappearance of T2. Patients of N group will receive a dose of 50 ug/kg neostigmine after the last dose of rocuronium, at reappearance of T2. The primary endpoint is time from start of administration of sugammadex or neostigmine to recovery of train-of-four stimulation ratio (TOFr) to 0.9. Secondary end points include time from start of administration of sugammadex or neostigmine to recovery of TOFr to 0.8 and 0.7, time to extubation, clinical signs of neuromuscular recovery, hemodynamic changes after muscle relaxation antagonism, adverse effects, time to operating room (OR) discharge, time to post-anesthesia care unit (PACU) discharge, and pulmonary complications within 7 days after the operation.

2024-06-01

2024-10-31

2025-06-30

Not yet recruiting

64

Inclusion Criteria: * • Patients with MG scheduled for elective thoracoscopic thymectomy * Aged 18 to 65 years * American society of Anesthesiologists (ASA) physical status classification system: I - III Exclusion Criteria: * Inability to obtain written informed consent * With severe renal or hepatic dysfunction * A plan to return to ICU with intubation postoperation * A family history of malignant hyperthermia * Suspected difficult airway * Allergy to medications involved in the study * A contraindication for neostigmine or sugammadex administration * The patient's arm is not available for neuromuscular monitoring * Patients receiving medication known to interfere with NMBAs (e.g., anticonvulsants, antibiotics, magnesium salts) * Pregnant or lactating patients

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2024-05-31